# EUR-Lex - 52013PC0487 - EN

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# 52013PC0487

**Amended proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, in the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community Acts on the territory of the Principality of Monaco /* COM/2013/0487 final - 2013/0116 (NLE) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

The Agreement between the European
Community and the Principality of Monaco on the application of certain
Community Acts on the territory of the Principality of Monaco of 4 December
2003[1] facilitates economic activities
and trade in medicines for human and veterinary use, cosmetic products and
medical devices between the Parties to the Agreement.

The Agreement provides in its Article 1,
paragraph 1, that the Joint Committee established by the Agreement shall amend
its Annex to ensure that European Union Acts falling within the scope of the
Agreement apply on the territory of Monaco.

The Annex to the Agreement has never been
updated since its entry into force in 2004. Since then, the European Union has
adopted a number of acts that fall within the scope of the Agreement and some
acts appearing in the Annex have been repealed.

In addition, it is necessary to include
acts falling within the scope of the Agreement but not currently referenced in
the Annex, including Directives 2002/98/EC and 2004/23/EC because certain of
their provisions apply to the manufacturing of medicinal products.

The present proposal therefore aims to update and revise the Annex so that it includes all
EU acts falling within the scope of the Agreement and to remove the acts
that have been repealed. In order to establish the position to be taken on
behalf of the Union in the Joint Committee, a Council Decision is necessary.

2.           LEGAL ELEMENTS OF THE
PROPOSAL

Summary of the proposed action

This is a proposal for a Council Decision
on the position to be taken on behalf of the Union within the Joint Committee
established by the Agreement, which should be based on the draft Joint
Committee Decision in annex.

Legal basis

Article 207 of the Treaty on the
Functioning of the European Union in conjunction with Article 218(9) thereof.

Choice of instrument

Article 218(9) of the Treaty on the
Functioning of the European Union provides that a Council Decision establishes
the position to be adopted on behalf of the European Union in a body set up by
an agreement, when that body is called upon to adopt decisions having legal
effects.

Proportionality

The proposal is in line with the principle
of proportionality because its effects are strictly limited to what is
necessary to update the Annex to the Agreement to reflect the state of EU
legislation in the areas falling within its scope.

2013/0116 (NLE)

Amended proposal for a

COUNCIL DECISION

on the position to be adopted, on behalf
of the European Union, in the Joint Committee established by the Agreement
between the European Community and the Principality of Monaco on the
application of certain Community Acts on the territory of the Principality of
Monaco

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 207 in conjunction
with Article 218(9) thereof,

Having regard to Council
Decision 2003/885/EC of 17 November 2003 concerning the conclusion of the
Agreement on the application of certain Community Acts on the territory of the
Principality of Monaco[2], and in particular Article 3(2) thereof,

Having regard to the proposal from the
European Commission,

Whereas:

(1)       The Agreement between the
European Community and the Principality of Monaco on the application of certain
Community Acts on the territory of the Principality of Monaco of 4 December
2003[3] ('the
Agreement') entered into force on 1 May 2004.

(2)       The Agreement provides in
its Article 1(1) paragraph 1,
that the Joint Committee established by the Agreement is to
shall amend its Annex to ensure that Union Acts
falling within the scope of the Agreement apply on the territory of Monaco.

(3)       Since the entry into force
of the Agreement, the European Union has adopted a number of acts that fall
within its scope and some acts appearing in the Annex have been repealed. It is
therefore necessary to update the Annex to include the new acts and to remove
the acts that have been repealed. In addition, it is
necessary to include acts falling within the scope of the Agreement but not
currently referenced in the Annex, including Directives 2002/98/EC and
2004/23/EC because certain of their provisions apply to the manufacturing of
medicinal products.

(5)       The
position of the Union in the Joint Committee should be based on the attached
draft Decision.

Council Decision 2003/885/EC of 17 November 2003 on the conclusion
of the Agreement on the application of certain Community Acts on the territory
of the Principality of Monaco, notably its article 3, paragraph 1, provides
that the European Union shall be represented by the Commission on the Joint
Committee,

(6)       Council
Decision 2003/885/EC of 17 November 2003, notably its article 3, paragraph 2,
provides that the position to be taken by the European Union in the Joint
Committee shall be determined by the Council on a proposal from the Commission;
the Council shall act by the same voting rule as that applicable for the
adoption of the Union act concerned,

HAS ADOPTED THIS DECISION:

Article 1

The position to be taken by the European
Union within the Joint Committee set up by the Agreement between the European
Community and the Principality of Monaco on the application of certain
Community Acts on the territory of the Principality of Monaco of 4 December 2003 shall be based on the draft Decision of
the Joint Committee attached to this Decision.

Technical modificationsMinor changes to
the draft Decision may be agreed to by the representatives of the Union in the Joint Committee without further decision of the Council.

Article 2

The Decision of the Joint Committee shall
be published in the Official Journal of the European Union.

Article 3

This
Decision shall enter into force on the day of its adoption.

This Decision is addressed to the Member States in accordance with
the Treaties.

Done at Brussels,

For
the Council

The
President

Draft

DECISION
No. ... OF THE EU-MONACO JOINT COMMITTEE

of...

Aamending the Annex to the Agreement

THE JOINT COMMITTEE,

Having regard to the Agreement between the
European Community and the Principality of Monaco on the application of certain
Community Acts on the territory of the Principality of Monaco, signed in Brussels of 4 December
2003[4], hereinafter
referred to as 'the Agreement', and in particular Article 1(1) paragraph 1 thereof,

Whereas:

(1)
The Agreement between
the European Community and the Principality of Monaco on the application of
certain Community Acts on the territory of the Principality of Monaco of 4
December 2003[5]
entered into force on 1 May 2004,

(2)
The Agreement
provides in its Article 1, paragraph 1, that the Joint Committee established by
the Agreement shall amend its Annex to ensure that European Union acts falling
within the scope of the Agreement apply on the territory of Monaco,

(1)          Since the entry into force
of the Agreement on 1 May 2004, the European Union has adopted a number of acts
that fall within its scope and some acts appearing in the Annex have been
repealed. A Decision of the Joint Committee is therefore necessary to update
the Annex to include the new acts and to remove the acts that have been
repealed,

(2)          It is recalled that acts
of the European Commission adopted in application of the acts listed in the
Annex to the Agreement are applicable on the territory of Monaco without the
need for a Joint Committee Decision, as provided for by Article 1(2) paragraph
2 of the Agreement,

HAS ADOPTED THIS DECISION:

Article 1

The Annex to the Agreement between the
European Community and the Principality of Monaco on the application of certain
Community Acts on the territory of the Principality of Monaco of 4 December 2003 is hereby
replaced by the text set out in the Annex to this
Decision.

Article 2

This Decision shall enter into force on the
day of its adoption.

Date:

By
the Joint Committee

The
Chairman

"ANNEX

To Decision No. ... of the Committee established by the Agreement
between the European Community and the Principality of Monaco on the
application of certain Community acts on the territory of the Principality of
Monaco of 4 December 2003

I. MEDICINAL PRODUCTS

ACTS REFERRED TO

1.
Directive 2001/83/EC of the European Parliament
and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use

–
Amended by Directive 2012/26/EU of the European
Parliament and of the Council of 25 October 2012 as regards pharmacovigilance
(OJ L 299, 27.10.2012, p. 1–4)

–
Amended by Directive 2011/62/EU of the European
Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on
the Community code relating to medicinal products for human use, as regards the
prevention of the entry into the legal supply chain of falsified medicinal
products(Official Journal L174, 1.7.2011, p. 74-87)

–
Amended by Directive 2010/84/EU of the European
Parliament and of the Council of 15 December 2010 amending, as regards
pharmacovigilance, Directive 2001/83/EC on the Community code relating to
medicinal products for human use. (Official Journal L 348, 31.12.2010, p. 74 - 99).

–
Amended by Commission Directive 2009/120/EC of
14 September 2009 amending Directive 2001/83/EC of the European Parliament and
of the Council on the Community code relating to medicinal products for human
use as regards advanced therapy medicinal products (Official Journal L 242
15.9.2009, p. 3 - 12) .

–
Amended by Directive 2009/53/EC of the European
Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and
Directive 2001/83/EC, as regards variations to the terms of marketing
authorisations for medicinal products. (Official Journal L 168, 30.6.2009, p.
33 - 34).

–
Amended by Directive 2008/29/EC of the European
Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on
the Community code relating to medicinal products for human use, as regards the
implementing powers conferred on the Commission (Official Journal L 81,
20.3.2008, p. 51 - 52 ).

–
Amended by Regulation (EC) No 1394/2007 of the
European Parliament and of the Council of 13 November 2007 on advanced therapy
medicinal products and amending Directive 2001/83/EC and Regulation (EC) No
726/2004 (Official Journal L 324, 10.12.2007, p. 121-137)

–
Amended by Regulation (EC) No 1901/2006 of the
European Parliament and of the Council of 12 December 2006 on medicinal
products for paediatric use and amending Regulation (EEC) No 1768/92, Directive
2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Official
Journal L 378, 27.12.2006, p. 1-19).

–
Amended by Directive 2004/27/EC of the European
Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on
the Community code relating to medicinal products for human use (Official
Journal L 136, 30.4.2004, p. 34-57).

–
Amended by Directive 2004/24/EC of the European
Parliament and of the Council of 31 March 2004 amending, as regards traditional
herbal medicinal products, Directive 2001/83/EC on the Community code relating
to medicinal products for human use (Official Journal L 136, 30.4.2004, p.
85-90).

–
Amended by Commission Directive 2003/63/EC of 25
June 2003 amending Directive 2001/83/EC of the European Parliament and of the
Council on the Community code relating to medicinal products for human use
(Official Journal L 159, 27.6.2003, p. 46-94)

–
Amended by Directive 2002/98/EC of the European
Parliament and of the Council of 27 January 2003 setting standards of quality
and safety for the collection, testing, processing, storage and distribution of
human blood and blood components and amending Directive 2001/83/EC (Official
Journal L 33, 8.2.2003, p 30-40)

2.
Regulation (EC) No 726/2004 of the European
Parliament and of the Council of 31 March 2004 laying down Community procedures
for the authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Medicines Agency

–
Amended by Regulation (EU) no 1027/2012 of the
European Parliament and of the Council of 25 October 2012 as regards
pharmacovigilance. (OJ L 316, 14.11.2012, p. 38-40)

–
Amended by Regulation (EU) No 1235/2010 of the
European Parliament and of the Council of 15 December 2010 amending, as regards
pharmacovigilance of medicinal products for human use, Regulation (EC) No
726/2004 laying down Community procedures for the authorisation and supervision
of medicinal products for human and veterinary use and establishing a European
Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy
medicinal products Text with EEA relevance (OJ L 348, 31.12.2010, p. 1–16)

–
Amended by Regulation (EC) No 470/2009 of the
European Parliament and of the Council of 6 May 2009 laying down Community
procedures for the establishment of residue limits of pharmacologically active
substances in foodstuffs of animal origin, repealing Council Regulation (EEC)
No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of
the Council and Regulation (EC) No 726/2004 of the European Parliament and of
the Council (Official Journal L 152, 16.6.2009 p. 11 - 22).

–
Amended by Regulation (EC) No 219/2009 of the
European Parliament and of the Council of 11 March 2009 adapting a number of
instruments subject to the procedure referred to in Article 251 of the Treaty
to Council Decision 1999/468/EC with regard to the regulatory procedure with
scrutiny Adaptation to the regulatory procedure with scrutiny - Part Two
(Official Journal L 87, 231.3.2009, p. 109 - 154, especially p. 116 - 118,
Annex 2.9, where Regulation (EC) No 726/2004 is adapted).

– Amended by Regulation (EC) No 1394/2007 of the European Parliament
and of the Council of 13 November 2007 on advanced therapy medicinal products
and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. ( Official Journal L 324 10.12.2007,
p. 121-137)

–
Amended by Regulation (EC) No 1901/2006 of the
European Parliament and of the Council of 12 December 2006 on medicinal
products for paediatric use and amending Regulation (EEC) No 1768/92, Directive
2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. (Official
Journal L 378, 27.12.2006, p. 1–19)

3.
Directive 2001/82/EC of the European Parliament
and of the Council of 6 November 2001 on the Community code relating to
veterinary medicinal products

–
Amended by Regulation (EC) No 596/2009
of the European Parliament and of the Council of 18 June 2009 adapting a
number of instruments subject to the procedure referred to in Article 251 of
the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure
with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part
Four (Official Journal L 188, 18.7.2009, p. 14-92)

–
Amended by Directive 2009/53/EC of the
European Parliament and of the Council of 18 June 2009 amending Directive
2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of
marketing authorisations for medicinal products (Official Journal L 168,
30.6.2009, p. 33-34)

–
Amended by Regulation (EC) No 470/2009 of
the European Parliament and of the Council of 6 May 2009 laying down Community
procedures for the establishment of residue limits of pharmacologically active
substances in foodstuffs of animal origin, repealing Council Regulation (EEC)
No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of
the Council and Regulation (EC) No 726/2004 of the European Parliament and of
the Council ( Official Journal L 152, 16.6.2009, p. 11-22)

–
Amended by Commission Directive 2009/9/EC
of 10 February 2009 amending Directive 2001/82/EC of the European Parliament
and of the Council on the Community code relating to medicinal products for
veterinary use (Official Journal L 44, 14.2.2009, p.10-61)

–
Amended by Directive 2004/28/EC of the
European Parliament and of the Council of 31 March 2004 amending Directive
2001/82/EC on the Community code relating to veterinary medicinal products
(Official Journal L 136, 30.4.2004, p. 58-84)

4.
Council Regulation (EC) No 297/95 of 10 February
1995 on fees payable to the European Agency for the Evaluation of Medicinal
Products

–
Amended by Council Regulation (EC) No
2743/98 of 14 December 1998

–
Amended by Commission Regulation (EC) No
494/2003 of 18 March 2003

–
Amended by Council Regulation (EC) No
1905/2005 of 14 November 2005

–
Amended by Commission Regulation (EC) No
312/2008 of 3 April 2008

–
Amended by Commission Regulation (EC) No
249/2009 of 23 March 2009

–
Amended by Commission Regulation (EU) No
261/2010 of 25 March 2010

–
Amended by Commission Regulation (EU) No
301/2011 of 28 March 2011

–
Amended by Commission Regulation (EU) No
273/2012 of 27 March 2012

–
Amended by Commission
Regulation (EU) No 220/2013 of 13 March 2013

5.
Regulation (EC) No 470/2009 of the European
Parliament and of the Council of 6 May 2009 laying down Community procedures
for the establishment of residue limits of pharmacologically active substances
in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90
and amending Directive 2001/82/EC of the European Parliament and of the Council
and Regulation (EC) No 726/2004 of the European Parliament and of the Council
(Official Journal L 152, 16/6/2009 p. 11 - 22).

6.
Commission Regulation (EC) No 668/2009 of 24
July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament
and of the Council with regard to the evaluation and certification of quality
and non-clinical data relating to advanced therapy medicinal products developed
by micro, small and medium-sized enterprises (Official Journal L 194, 25/7/2009
p. 7 - 10).

7.
Commission Regulation (EU) N° 37/2010 of 22
December 2009 on pharmacologically active substances and their classification
regarding maximum residue limits in foodstuffs of animal origin

–
Amended by Commission Regulation (EU) No
758/2010 of 24 August 2010

–
Amended by Commission Regulation (EU) No
759/2010 of 24 August 2010

–
Amended by Commission Regulation (EU) No
761/2010 of 25 August 2010

–
Amended by Commission Regulation (EU) No
890/2010 of 8 October 2010

–
Amended by Commission Regulation (EU) No
914/2010 of 12 October 2010

–
Amended by Commission Regulation (EU) No
362/2011 of 13 April 2011

–
Amended by Commission Regulation (EU) No
363/2011 of 13 April 2011

–
Amended by Commission Implementing Regulation
(EU) No 84/2012 of 1 February 2012

–
Amended by Commission Implementing Regulation
(EU) No 85/2012 of 1 February 2012

–
Amended by Commission Implementing Regulation
(EU) No 86/2012 of 1 February 2012

–
Amended by Commission Implementing Regulation
(EU) No 107/2012 of 8 February 2012

–
Amended by Commission Implementing Regulation
(EU) No 122/2012 of 13 February 2012

–
Amended by Commission Implementing Regulation
(EU) No 123/2012 of 13 February 2012

–
Amended by Commission Implementing Regulation
(EU) No 201/2012 of 8 March 2012

–
Amended by Commission Implementing Regulation
(EU) No 202/2012 of 8 March 2012

–
Amended by Commission Implementing Regulation
(EU) No 221/2012 of 14 March 2012

–
Amended by Commission Implementing Regulation
(EU) No 222/2012 of 14 March 2012

–
Amended by Commission Implementing Regulation
(EU) No 436/2012 of 23 May 2012

–
Amended by Commission Implementing Regulation
(EU) No 466/2012 of 1 June 2012

–
Amended by Commission Implementing Regulation
(EU) No 1161/2012 of 7 December 2012

–
Amended by Commission Implementing Regulation
(EU) No 1186/2012 of 11 December 2012

–
Amended by Commission Implementing Regulation
(EU) No 1191/2012 of 12 December 2012

–
Amended by Commission
Implementing Regulation (EU) No 59/2013 of 23 January 2013

–
Amended by Commission
Implementing Regulation (EU) No 115/2013 of 8 February 2013

–
Amended by Commission
Implementing Regulation (EU) No 116/2013 of 8 February 2013

–
Amended by Commission
Implementing Regulation (EU) No 394/2013 of 29 April 2013

–
Amended by Commission
Implementing Regulation (EU) No 406/2013 of 2 May 2013

8.
Commission Regulation (EU) No 488/2012 of 8 June
2012 amending Regulation (EC) No 658/2007 concerning financial penalties for
infringement of certain obligations in connection with marketing authorisations
granted under Regulation (EC) No 726/2004 of the European Parliament and of the
Council (OJ L 150, 9.6.2012, p. 68–70)

9.
Commission Regulation (EC) No 1234/2008 of 24
November 2008 concerning the examination of variations to the terms of
marketing authorisations for medicinal products for human use and veterinary
medicinal products

–
Amended by Commission Regulation (EU) No
712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the
examination of variations to the terms of marketing authorisations for
medicinal products for human use and veterinary medicinal products (Official
Journal L 209, 4.8.2012, p. 4 - 14).

10.
Commission Implementing Regulation (EU)
No 198/2013 of 7 March 2013 on the selection of a symbol for the
purpose of identifying medicinal products for human use that are subject to
additional monitoring (Official Journal L
65, 8/3/2013, p. 17–18)

11. Directive 2010/63/EU of the European Parliament
and of the Council of 22 September 2010 on the protection of animals used
for scientific purposes (Official Journal, L 276, 20.10.2010, p. 33–79)

12.
Regulation (EC) No 469/2009 of the European
Parliament and of the Council of 6 May 2009 concerning the supplementary
protection certificate for medicinal products (Official Journal L 152,
16.6.2009, p. 1–10)

13.
Directive 2009/35/EC of the European Parliament
and of the Council of 23 April 2009 on the colouring matters which may be added
to medicinal products (Official Journal L 109, 30.4.2009, p. 10–13)

14.
Regulation (EC) No 1394/2007 of the European
Parliament and of the Council of 13 November 2007 on advanced therapy medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Official
Journal L 324, 10.12.2007, p. 121–137)

–
Amended by Regulation (EU) No 1235/2010 of the
European Parliament and of the Council of 15 December
2010

15.
Commission Regulation (EC) No 658/2007 of
14 June 2007 concerning financial penalties for infringement of certain
obligations in connection with marketing authorisations granted under
Regulation (EC) No 726/2004 of the European Parliament and of the Council
(Official Journal L 155, 15.6.2007, p. 10–19)

16.
Regulation (EC) No 1901/2006 of the European Parliament
and of the Council of 12 December 2006 on medicinal products for paediatric use
and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive
2001/83/EC and Regulation (EC) No 726/2004 (Official Journal L 378, 27.12.2006,
p. 1–19)

–
Amended by Regulation (EC) No 469/2009 of the
European Parliament and of the Council of 6 May 2009

–
Amended by Regulation (EC) No 1902/2006 of the
European Parliament and of the Council of 20 December 2006

17.
Commission Regulation (EC) No 507/2006 of 29
March 2006 on the conditional marketing authorisation for medicinal products
for human use falling within the scope of Regulation (EC) No 726/2004 of the
European Parliament and of the Council (Official Journal L 92, 30.3.2006, p.
6–9)

18.
Commission Regulation (EC) No 2049/2005 of
15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of
the European Parliament and of the Council, rules regarding the payment of fees
to, and the receipt of administrative assistance from, the European Medicines
Agency by micro, small and medium-sized enterprises (Official Journal L 329,
16.12.2005, p. 4–7)

19.
Commission Directive 2005/28/EC of 8 April 2005
laying down principles and detailed guidelines for good clinical practice as
regards investigational medicinal products for human use, as well as the
requirements for authorisation of the manufacturing or importation of such
products(Official Journal L 91, 9.4.2005, p. 13–19)

20.
Directive 2004/10/EC of the European Parliament
and of the Council of 11 February 2004 on the harmonisation of laws,
regulations and administrative provisions relating to the application of the
principles of good laboratory practice and the verification of their
applications for tests on chemical substances ( Official Journal L 50,
20.2.2004, p. 44–59)

–
Amended by Regulation (EC) No 219/2009 of the
European Parliament and of the Council of 11 March 2009

21.
Directive 2004/9/EC of the European Parliament
and of the Council of 11 February 2004 on the inspection and verification of
good laboratory practice (GLP) (Official Journal L 50, 20.2.2004, p. 28–43)

–
Amended by Regulation (EC) No 219/2009 of the
European Parliament and of the Council of 11 March 2009

22.
Commission Directive 2003/94/EC of 8 October
2003 laying down the principles and guidelines of good manufacturing practice
in respect of medicinal products for human use and investigational medicinal
products for human use (Official Journal L 262, 14.10.2003, p. 22–26)

23.
Council Regulation (EC) No 953/2003 of 26 May
2003 to avoid trade diversion into the European Union of certain key medicines
( Official Journal L 135, 3.6.2003, p. 5–11)

–
Amended by Commission Regulation (EC) No
1876/2004 of 28 October 2004

–
Amended by Commission Regulation (EC) No
1662/2005 of 11 October 2005

24.
Regulation (EC) No 141/2000 of the European
Parliament and of the Council of 16 December 1999 on orphan medicinal products
(Official Journal L 18, 22.1.2000)

–
Amended by Regulation (EC) No 596/2009 of the
European Parliament and of the Council of 18 June 2009

25. Commission Directive
91/412/EEC of 23 July 1991 laying down the principles and guidelines of good
manufacturing practice for veterinary medicinal products (Official Journal L
228 du 17.8.1991, p. 70–73) Directive 91/412/CEE de
la Commission, du 23 juillet 1991, établissant les principes et lignes
directrices de bonnes pratiques de fabrication pour les médicaments
vétérinaires (Official Journal L 228 du 17.8.1991, p. 70–73)

26. Council Directive 89/105/EEC of 21 December 1988
relating to the transparency of measures regulating the prices of medicinal
products for human use and their inclusion in the scope of national health
insurance systems. (Official Journal L 40 of
11.2.1989, p. 8–11) Directive 89/105/CEE du Conseil
du 21 décembre 1988 concernant la transparence des mesures régissant la
fixation des prix des médicaments à usage humain et leur inclusion dans le
champ d'application des systèmes d'assurance-maladie (Official Journal L 40 of
11.02.1989, p. 8–11)

27. Directive 2001/20/EC of the European Parliament
and of the Council of 4 April 2001 on the approximation of the laws,
regulations and administrative provisions of the Member States relating to the
implementation of good clinical practice in the conduct of clinical trials on
medicinal products for human use (Official Journal L 121 of 1.5.2001, p. 34-44)

–
- Amended by Regulation (EC) No
1901/2006 of the European Parliament and of the Council of 12 December 2006 (OJ
L 378, 27.12.2006, p. 1);

–
- Amended by Regulation (EC) No 596/2009
of the European Parliament and of the Council of 18 June 2009 (OJ L 188,
18.7.2009, p. 14).

28. Directive 2002/98/EC of the European Parliament
and of the Council of 27 January 2003 setting standards of quality and safety
for the collection testing, processing, storage and distribution of human blood
and blood components and amending Directive 2001/83/EC (OJ L 33 of 8.2.2003, p.
30) (only as regards insofar
as it is applicable to the
collection and testing of blood and blood components used as starting materials
for manufacturing medicinal products).

29. Directive 2004/23/EC of the European Parliament
and of the Council of 31 March 2004 on setting standards of quality and safety
for the donation, procurement, resting, processing, preservation, storage and
distribution of human tissues and cells (OJ L 102, 7.4.2004, p.48) (only as
regards insofar as it is
applicable tothe procurement,
donation, coding and testing of tissue and cells, as well as the coding of
donations and packaging thereof, used as starting materials for advanced
therapy medicinal products as referred to in Regulation (EC) No 1394/2007 of
the European Parliament and of the Council)

II. COSMETICS

ACTS REFERRED TO

1.
Council Directive 76/768/EEC of 27 July 1976 on
the approximation of the laws of the Member States relating to cosmetic
products (OJ L 262, 27.9.1976, p. 169), as amended by:

–
Council Directive 79/661/EEC of 24 July 1979 (OJ
L 192, 31.7.1979, p.35)

–
Commission Directive 82/147/EEC of 11 February
1982 (OJ L 63, 6.3.1982, p. 26)

–
Council Directive 82/368/EEC of 17 May 1982 (OJ
L 167, 15.6.1982, p. 1)

–
Commission Directive 83/191/EEC of 30 March 1983
(OJ L 109, 26.4.1983, p.25)

–
Commission Directive 83/341/EEC of 29 June 1983
(OJ L 188, 13.7.1983, p. 15)

–
Commission Directive 83/496/EEC of 22 September
1983 (OJ L 275, 8.10.1983, p. 20)

–
Council Directive 83/574/EEC of 26 October 1983
(OJ L 332, 28.11.1983, p. 38)

–
Commission Directive 84/415/EEC of 18 July 1984
(OJ L 228, 25.8.1984, p. 31)

–
Commission Directive 85/391/EEC of 16 July 1985
(OJ L 224, 22.8.1985, p.40)

–
Commission Directive 86/179/EEC of 28 February
1986 (OJ L 138, 24.5.1986, p. 40)

–
Commission Directive 86/199/EEC of 26 March 1986
(OJ L 149, 3.6.1986, p. 38)

–
Commission Directive 87/137/EEC of 2 February
1987 (OJ L 56, 26.2.1987, p. 20)

–
Commission Directive 88/233/EEC of 2 March 1988
(OJ L 105, 26.4.1988, p.11)

–
Council Directive 88/667/EEC of 21 December 1988
(OJ L 382, 31.12.1988, p.46)

–
Commission Directive 89/174/EEC of 21 February
1989 (OJ L 64, 8.3.1989, p. 10)

–
Council Directive 89/679/EEC of 21 December 1989
(OJ L 398, 30.12.1989, p.25)

–
Commission Directive 90/121/EEC of 20 February
1990 (OJ L 71, 17.3.1990, p. 40)

–
Commission Directive 91/184/EEC of 12 March 1991
(OJ L 91, 12.4.1991, p. 59)

–
Commission Directive 92/8/EEC of 18 February
1992 (OJ L 70, 17.3.1992, p. 23)

–
Commission Directive 92/86/EEC of 21 October 1992
(OJ L 325, 11.11.1992, p. 18)

–
Council Directive 93/35/EEC of 14 June 1993 (OJ
L 151, 23.6.1993, p. 32)

–
Commission Directive 93/47/EEC of 22 June 1993
(OJ L 203, 13.8.1993, p. 24)

–
Commission Directive 94/32/EC of 29 June 1994
(OJ L 181, 15.7.1994, p. 31)

–
Commission Directive 95/34/EC of 10 July 1995
(OJ L 167, 18.7.1995, p. 19)

–
Commission Directive 96/41/EC of 25 June 1996
(OJ L 1988.8.1996, p. 36)

–
Commission Directive 97/1/EC of 10 January 1997
(OJ L 16, 18.1.1997, p. 85)

–
Commission Directive 97/18/EC of 17 April l997
(OJ L 114, 1.5.1997, p. 43)

–
Commission Directive 97/45/EC of 14 July 1997
(OJ L 196, 24.7.1997, p. 77)

–
Commission Directive 98/16/EC of 5 March 1998
(OJ L 77, 14.3.1998, p. 44)

–
Commission Directive 98/62/EC of 3 September
1998 (OJ L 253, 15.9.1998, p. 20)

–
Commission Directive 2000/6/EC of 29 February
2000 (OJ L 56, 1.3.2000, p. 42)

–
Commission Directive 2000/11/EC of 10 March 2000
(OJ L 65, 14.3.2000, p. 22)

–
Commission Directive 2000/41/EC of 19 June 2000
(OJ L 145, 20.6.2000, p. 25)

–
Commission Directive 2002/34/EC of 15 April 2002
(OJ L 102, 18.4.2002, p. 19)

–
Commission Directive 2003/1/EC of 6 January 2003
(L 5, 10.1.2003, p. 14)

–
Commission Directive 2003/16/EC of 19 February
2003 (OJ L 46, 20.2.2003, p. 24)

–
Directive 2003/15/EC of the European Parliament
and of the Council of 27 February 2003 (OJ L 66, 11.3.2003, p. 26)

–
Commission Directive 2003/80/EC of 5 September
2003 (OJ L 224, 6.9.2003, p. 27)

–
Commission Directive 2003/83/EC of 24 September
2003 (OJ L 238, 25.9.2003, p. 23)

–
Commission Directive 2004/87/EC of 7 September
2004 (OJ L 287, 8.9.2004, p. 4)

–
Commission Directive 2004/88/EC of 7 September
2004 (OJ L 287, 8.9.2004, p. 5)

–
Commission Directive 2004/94/EC of 15 September
2004 (OJ L 294, 17.9.2004, p. 28)

–
Commission Directive 2004/93/EC of 21 September
2004 (OJ L 300, 25.9.2004, p. 13)

–
Commission Directive 2005/9/EC of 28 January
2005 (OJ L 27, 29.1.2005, p. 46)

–
Commission Directive 2005/42/EC of 20 June 2005
(OJ L 158, 21.6.2005, p. 17)

–
Commission Directive 2005/52/EC of 9 September 2005
(OJ L 234, 10.9.2005, p. 9)

–
Commission Directive 2005/80/EC of 21 November
2005 (OJ L 303, 22.11.2005, p. 32)

–
Commission Directive 2006/65/EC of 19 July 2006
(OJ L 198, 20.7.2006, p. 11)

–
Commission Directive 2006/78/EC of 29 September
2006 (OJ L 271, 30.9.2006, p. 56)

–
Commission Directive 2007/1/EC of 29 January
2007 (OJ L 25, 1.2.2007, p. 9)

–
Commission Directive 2007/17/EC of 22 March 2007
(OJ L 82, 23.3.2007, p. 27)

–
Commission Directive 2007/22/EC of 17 April 2007
(OJ L 101, 18.4.2007, p. 11)

–
Commission Directive 2007/53/EC of 29 August
2007 (OJ L 226, 30.8.2007, p. 19)

–
Commission Directive 2007/54/EC of 29 August
2007 (OJ L 226, 30.8.2007, p. 21)

–
Commission Directive 2007/67/EC of 22 November
2007 (OJ L 305, 23.11.2007, p. 22)

–
Commission Directive 2008/14/EC of 15 February
2008 (OJ L 42, 16.2.2008, p. 43)

–
Commission Directive 2008/42/EC of 3 April 2008
(OJ L 93, 4.4.2008, p. 13)

–
Commission Directive 2008/88/EC of 23 September
2008 (OJ L 256, 24.9.2008, p. 12)

–
Commission Directive 2008/123/EC of 18 December
2008 (OJ L 340, 19.12.2008, p. 71)

–
Directive 2008/112/EC of the European Parliament
and of the Council of 16 December 2008 (L 345, 23.12.2008, p. 68)

–
Commission Directive 2009/6/EC of 4 February
2009 (L 36, 5.2.2009, p. 15)

–
Commission Directive 2009/36/EC of 16 April 2009
(OJ L 98, 17.4.2009, p. 31)

–
Commission Directive 2009/129/EC of 9 October
2009 (L 267, 10.10.2009, p. 18)

–
Commission Directive 2009/130/EC of 12 October
2009 (L 268, 13.10.2009, p. 5)

–
Commission Directive 2009/134/EC of 28 October
2009 (L 282, 29.10.2009, p. 15)

–
Commission Directive 2009/159/EU of 16 December
2009 (OJ L 336, 18.12.2009, p. 29)

–
Regulation (EC) No 1223/2009 of the European
Parliament and of the Council of 30 November 2009 (OJ L 342, 22.12.2009, p. 59)

–
Commission Directive 2009/164/EU of 22 December
2009 (OJ L 344, 23.12.2009, p. 41)

–
Commission Directive 2010/3/EU of 1 February
2010 (OJ L 29, 2.2.2010, p. 5)

–
Commission Directive 2010/4/EU of 8 February
2010 (OJ L 36, 9.2.2010, p. 21)

–
Commission Directive 2011/59/EU of 13 May 2011
(OJ L 125, 14.5.2011, p. 17)

–
Council Directive 2011/84/EU of 20 September
2011 (OJ L 283, 29.10.2011, p. 36)

–
Commission Implementing Directive 2012/21/EU of
2 August 2012 (OJ L 208, 3.8.2012, p. 8)

Directive 76/768/EEC will be repealed with
effect from 11 July 2013 and will be replaced by: Regulation
(EC) No 1223/2009 of the European Parliament and of the Council of 30 November
2009 on cosmetic products.

2.
Regulation (EC) No 1223/2009 of the European
Parliament and of the Council of 30 November 2009 on cosmetic products. (OJ L
342, 22.12.2009, p.59), as amended by:

–
Commission Regulation
(EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to
Regulation (EC) No 1223/2009 of the European Parliament and of the Council on
cosmetic products (OJ L 114, 25.4.2013, p. 1)

–
Commission Regulation
(EU) No 483/2013 of 24 May 2013 amending Annex III to Regulation (EC) No
1223/2009 of the European Parliament and of the Council on cosmetic products
(OJ L 139, 25.5.2013, p.8)

3.
Commission Directive 80/1335/EEC of 22 December
1980 on the approximation of the laws of the Member States relating to methods
of analysis necessary for checking the composition of cosmetic products (OJ L
383, 31.12.1980, p. 27), as amended by:

–
Commission Directive 87/143/EEC of 10 February
1987 (OJ L 57, 27.2.1987, p. 56).

4.
Commission Directive 82/434/EEC of 14 May 1982
on the approximation of the laws of the Member States relating to methods of
analysis necessary for checking the composition of cosmetic products (OJ L 185,
30.6.1982, p. 1), as amended by:

–
Commission Directive 90/207/EEC of 4 April 1990
(OJ L 108, 28.4.1990, p. 92).

5.
Commission Directive 83/514/EEC of 27 September
1983 on the approximation of the laws of the Member States relating to methods
of analysis necessary for checking the composition of cosmetic products (OJ L
291, 24.10.1983, p. 9).

6.
Commission Directive 85/490/EEC of 11 October
1985 on the approximation of laws of the Member States relating to methods of
analysis necessary for checking the composition of cosmetic products (OJ L 295,
7.11.1985, p. 30).

7.
Commission Directive 93/73/EEC of 9 September
1993 on the methods of analysis necessary for checking the composition of
cosmetic products (OJ L 231, 14.9.1993, p. 34).

8.
Commission Directive 95/17/EC of 19 June 1995 laying
down detailed rules for the application of Council Directive 76/768/EEC as
regards the non-inclusion of one or more ingredients on the list used for the
labelling of cosmetic products (OJ L 140, 23.6.1995, p. 26).

–
Amended by Commission Directive 2006/81/EC of 23
October 2006 (OJ L 362, 20.12.2006, p. 92)

–
Amended by Act concerning the conditions of
accession of the Czech Republic, the Republic of Estonia, the Republic of
Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of
Hungary, the Republic of Malta, the Republic of Poland, the Republic of
Slovenia and the Slovak Republic and the adjustments to the Treaties on which
the European Union is founded (OJ L 236, 23.9.2003, p.33)

Commission Directive
95/17/EC This dDirective
will be repealed with effect from 11 July 2013.

9.
Commission Directive 95/32/EC of 7 July 1995
relating to methods of analysis necessary for checking the composition of
cosmetic products (OJ L 178, 28.7.1995, p. 20).

10.
Commission Directive 96/45/EC of 2 July 1996
relating to methods of analysis necessary for checking the composition of
cosmetic products (OJ L 213, 22.8.1996, p. 8).

11.
Commission Decision of 8 May 1996 establishing
an inventory and a common nomenclature of ingredients employed in cosmetic
products ( OJ L 132, 1.6.1996, p. 1––)

–
Amended by Commission Decision 2006/257/EC, (OJ
L 97, 5.4.2006, p. 1)

III. MEDICAL DEVICES

ACTS REFERRED TO

1.
Council Directive 90/385/EEC of 20 June 1990 on
the approximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17), as amended by:

–
Amended by Council Directive 93/42/EEC of 14
June 1993 (OJ L 169, 12.7.1993, p. 1).

–
Amended by Council Directive 93/68/EEC of 22
July 1993 (OJ L 220, 30.8.1993, p.1).

–
Amended by Regulation (EC) No 1882/2003 of the
European Parliament and of the Council of 29 September 2003 (OJ L 284,
31.10.2003, p. 1).

–
Amended by Directive 2007/47/EC of the European
Parliament and of the Council of 5 September 2007 (OJ L 247, 21.09.2007, p.
21).

2.
Council Directive 93/42/EEC of 14 June 1993
concerning medical devices (OJ L 169, 12.7.1993, p. 1).

–
Amended by Directive 98/79/EC of the European
Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical
devices (OJ L 331, 7.12.1998, p. 1).

–
Amended by Directive 2000/70/EC of the European
Parliament and of the Council of 16 November 2000 amending Council Directive
93/42/EEC as regards medical devices incorporating stable derivates of human
blood or human plasma (OJ L 313, 13.12.2000, p. 22).

–
Amended by Directive 2001/104/EC of the European
Parliament and of the Council of 7 December 2001 amending Council Directive
93/42/EEC concerning medical devices (OJ L 6, 10.1.2002, p. 50).

–
Amended by Regulation (EC) No 1882/2003 of the
European Parliament and of the Council of 29 September 2003 (OJ L 284,
31.10.2003, p.1).

–
Amended by Regulation (EC) No 1882/2003 of the
European Parliament and of the Council of 29 September 2003 (OJ L 284,
31.10.2003, p.1).

–
Amended by Directive 2007/47/EC of the European
Parliament and of the Council of 5 September 2007 (OJ L 247, 21.9.2007, p.21).

3.
Directive 98/79/EC of the European Parliament
and of the Council of 27 October 1998 on in vitro diagnostic medical devices
(OJ L 331, 7.12.1998, p. 1).

–
Amended by Regulation (EC) No 1882/2003 of the
European Parliament and of the Council of 29 September 2003 (OJ L 284,
31.10.2003, p. 1).

–
Amended by Regulation (EC) No 596/2009 of the
European Parliament and of the Council of 18 June 2009 (OJ L 188, 18.07.2009,
p.14).

–
Amended by Commission Directive 2011/100/EU of
20 December 2011 (OJ L 341, 22.12.2011, p. 50).

4.
Commission Decision 2002/364/EC of 7 May 2002 on
common technical specifications for in vitro diagnostic medical devices (OJ L
131, 16.5.2002, p.17)

–
Amended by Commission Decision 2009/108/EC of 3
February 2009 (OJ L 39, 10.02.2009, p.34).

–
Amended by Commission Decision 2009/886/EC of 27
November 2009 (OJ L 318, 4.12.2009, p.25).

–
Amended by Commission Decision 2011/869/EU of 20
December 2011 (OJ L 341, 22.12.2011, p.63).

5.
Commission Directive 2003/12/EC of 3 February
2003 on the reclassification of breast implants in the framework of Directive
93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p.43).

6.
Commission Directive 2003/32/EC of 23 April 2003
introducing detailed specifications as regards the requirements laid down in
Council Directive 93/42/EEC with respect to medical devices manufactured
utilising tissues of animal origin (OJ L 105, 26.4.2003, p.18).

7.
Commission Directive 2005/50/EC of 11 August
2005 on the reclassification of hip, knee and shoulder joint replacements in
the framework of Council Directive 93/42/EEC concerning medical devices (OJ L
210, 12.08.2005, p.41).

8.
Commission Decision 2010/227/EU of 19 April 2010
on the European Databank on Medical Devices (Eudamed) (OJ L102, 23.04.2010,
p.45).

9.
Commission Regulation (EU) No 207/2012 of 9
March 2012 on electronic instructions for use of medical devices (OJ L72,
10.03.2012, p.28).

10.
Commission Regulation (EU) No 722/2012 of 8
August 2012 concerning particular requirements as regards the requirements laid
down in Council Directives 90/385/EEC and 93/42/EEC with respect to active
implantable medical devices and medical devices manufactured utilising tissues
of animal origin (OJ 212, 9.08.2012, p.3)."

[1]               OJ L 332, 19.12.2003, pp.42-43.

[2]               OJ L 332, 19.12.2003, p.41.

[3]               OJ L 332, 19.12.2003, pp.42-43.

[4]               OJ L 332, 19.12.2003, pp.42-43.

[5]               OJ L 332, 19.12.2003, pp.42-43.